MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PULSERIDER T, 3MM, 8MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Model Number 201-D

Device Problems Patient-Device Incompatibility (2682); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2022

Event Type  Injury  

Event Description

The healthcare professional reported that during a pulserider-assisted coil embolization procedure targeting an unruptured basilar artery (ba) tip aneurysm, the complaint pulserider, a pulserider t shape, 8mm , 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d / 3076825513) was placed without any problem.A concomitant microcatheter, an excelsior® sl-10® microcatheter (stryker) was delivered to the target aneurysm to embolize fourteen (14) coils, but the physician ¿pointed out a strange feeling when inserting¿ the 1.00mm x 3.00cm galaxy g3 mini (glm910030 / k10700), which was used as the last coil.The complaint coil was removed from the patient and checked; it was observed to have unraveled.¿it was probably used at the end of coil embolization, and therefore, it was difficult to fit into the aneurysm and unraveled occurred when the complaint coil was taken in and out several times.¿ the complaint coil was removed and ¿imaged before detachment of the complaint pulserider.Because the coils were also located outside the pulserider, the pulserider was detached.Detachment was success and delivered around the leg with the prowler select plus microcatheter to confirm that the pulserider was detached.The final contrast was performed, and it was found that about three loops of the coil had deviated to the [parent] vessel.The excelsior® sl-10® microcatheter was guided to the right posterior cerebral artery (pca), from which a neuroform atlas® stent system (stryker) was placed and crimped on the vessel wall, and the procedure was completed safely.No adverse event occurred.¿ on 18-nov-2022, additional information was received.The information indicated that the sofia ¿ distal access catheter (microvention) was placed around the vertebral artery (va)-ba union; the pulserider implant migrated when the physician attempted to deploy the implant by unsheathing the implant legs from the microcatheter.On 05-dec-2022, the following additional information was received: the complaint coil, 1.00mm x 3.00cm galaxy g3 mini (glm910030) was removed; it is unknown which coil(s) the reported three loops of coil that deviated into the parent vessel belonged to.The information indicated that the three loops of coil that deviated into the parent vessel could not be identified; it was not from the complaint coil.There was no information related to the aneurysm size and characteristics.It is not known if the fourteen (14) coils that were used were cerenovus coils.The catalog and lot number of the prowler select plus microcatheter is not known; the pulserider was delivered via the prowler select plus microcatheter.There was no difficulty encountered during the pulserider positioning.When the pulserider anrd was detached, the implant was in the correct orientation.The information indicated that no other malfunction related to cerenovus device was reported.The statement, ¿the pulserider was detached.Detachment was success and delivered around the leg with the microcatheter (prowler select plus)¿ meant that the physician confirmed the success of the detachment by bringing the microcatheter close to the leg of the pulserider anrd and confirming that it did not move.The information indicated that the complaint coil was used with the excelsior® sl-10® microcatheter.There was no information related to whether there was difficulty getting the complaint coil to conform to the aneurysm, but the physician commented that ¿he felt something was wrong.¿ the complaint coil was repositioned ¿several times¿ but the number of times it was repositioned was not known.There was no information available as to whether the complaint coil was still attached to the delivery system when it was removed.Additional clarifying information was received on 07-dec-2022.The information indicated the following: it was originally reported that there was no difficulty encountered during the pulserider positioning.However, the information received clarified that ¿the pulserider temporally migrated during the attempt to un-sheath the implant to deploy it, but it was repositioned to the desired position in the end.¿ the pulserider anrd migrated temporally and was fixed at the desired position.It was ultimately detached and implanted in the correct orientation.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that during a pulserider-assisted coil embolization procedure targeting an unruptured basilar artery (ba) tip aneurysm, the complaint pulserider, a pulserider t shape, 8mm , 2.7 ¿ 3.5mm aneurysm neck reconstruction device (anrd) (201d / 3076825513) was placed without any problem.A concomitant microcatheter, an excelsior® sl-10® microcatheter (stryker) was delivered to the target aneurysm to embolize fourteen (14) coils, but the physician ¿pointed out a strange feeling when inserting¿ the 1.00mm x 3.00cm galaxy g3 mini (glm910030 / k10700), which was used as the last coil.The complaint coil was removed from the patient and checked; it was observed to have unraveled.¿it was probably used at the end of coil embolization, and therefore, it was difficult to fit into the aneurysm and unraveled occurred when the complaint coil was taken in and out several times.¿ the complaint coil was removed and ¿imaged before detachment of the complaint pulserider.Because the coils were also located outside the pulserider, the pulserider was detached.Detachment was success and delivered around the leg with the prowler select plus microcatheter to confirm that the pulserider was detached.The final contrast was performed, and it was found that about three loops of the coil had deviated to the [parent] vessel.The excelsior® sl-10® microcatheter was guided to the right posterior cerebral artery (pca), from which a neuroform atlas® stent system (stryker) was placed and crimped on the vessel wall, and the procedure was completed safely.No adverse event occurred.¿ on 18-nov-2022, additional information was received.The information indicated that the sofia ¿ distal access catheter (microvention) was placed around the vertebral artery (va)-ba union; the pulserider implant migrated when the physician attempted to deploy the implant by unsheathing the implant legs from the microcatheter.On 05-dec-2022, the following additional information was received: the complaint coil, 1.00mm x 3.00cm galaxy g3 mini (glm910030) was removed; it is unknown which coil(s) the reported three loops of coil that deviated into the parent vessel belonged to.The information indicated that the three loops of coil that deviated into the parent vessel could not be identified; it was not from the complaint coil.There was no information related to the aneurysm size and characteristics.It is not known if the fourteen (14) coils that were used were cerenovus coils.The catalog and lot number of the prowler select plus microcatheter is not known; the pulserider was delivered via the prowler select plus microcatheter.There was no difficulty encountered during the pulserider positioning.When the pulserider anrd was detached, the implant was in the correct orientation.The information indicated that no other malfunction related to cerenovus device was reported.The statement, ¿the pulserider was detached.Detachment was success and delivered around the leg with the microcatheter (prowler select plus)¿ meant that the physician confirmed the success of the detachment by bringing the microcatheter close to the leg of the pulserider anrd and confirming that it did not move.The information indicated that the complaint coil was used with the excelsior® sl-10® microcatheter.There was no information related to whether there was difficulty getting the complaint coil to conform to the aneurysm, but the physician commented that ¿he felt something was wrong.¿ the complaint coil was repositioned ¿several times¿ but the number of times it was repositioned was not known.There was no information available as to whether the complaint coil was still attached to the delivery system when it was removed.Additional clarifying information was received on 07-dec-2022.The information indicated the following: it was originally reported that there was no difficulty encountered during the pulserider positioning.However, the information received clarified that ¿the pulserider temporally migrated during the attempt to un-sheath the implant to deploy it, but it was repositioned to the desired position in the end.¿ the pulserider anrd migrated temporally and was fixed at the desired position.It was ultimately detached and implanted in the correct orientation.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (3076825513) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Per the information provided in the complaint, it appears that the pulserider anrd failed to maintain the coils within the confines of the target aneurysm.Coil herniation and coil protrusion into normal vessels through or around device is a known potential adverse event associated with the use of the pulserider anrd.If the pulserider anrd does not hold the embolic coils within the aneurysm sac, there could be thrombosis formation, which could lead to cerebral ischemia.According to the information received stating that the complaint pulserider anrd has temporally migrated position during its un-sheathing and had to be repositioned to the desired position before deployment, the relationship of the pulserider anrd to the reported event cannot be excluded.Since the reported event resulted in the need to perform additional intervention, the event is considered mdr reportable with the classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00814.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 19-dec-2022 and on 28-dec-2022.[additional information]: on 19-dec-2022, three video movies of the procedure were provided by the hospital and added to the complaint.The videos are pending independent physician review.A supplemental 3500a report will be submitted once the independent review has been completed.On 28-dec-2022, additional information was received; the information confirmed that the 1.00mm x 3.00cm galaxy g3 mini (glm910030 / k10700) was removed.The three (3) coil loops that deviated were not from the 1.00mm x 3.00cm galaxy g3 mini coil, ¿but other coil.¿ the 1.00mm x 3.00cm galaxy g3 mini was used with the excelsior sl-10 microcatheter.There was no difficulty getting the complaint coil to conform to the aneurysm wall.Detailed information on how many times the complaint coil had been withdrawn and re-inserted / repositioned could not be obtained.It was not known if the complaint coil or its device positioning unit had protruded from the introducer.When the coil was removed, it was not known if it was still attached to the delivery system.Information related to the aneurysm size and characteristics could not be obtained.Information related to the fourteen (14) coils and the catalog and lot number of the prowler select plus microcatheter could not be obtained; however, the information indicated that the pulserider anrd was delivered via the prowler select plus microcatheter.There was no difficulty encountered during the positioning of the pulserider anrd.When the pulserider anrd was detached, it was in the correct orientation.The information indicated that ¿the pulserider anrd was detached.Detachment was a success and delivered around the leg with the microcatheter (prowler select plus).No other cerenovus device had been used and/or malfunction.¿ e.1: (b)(6).Updated sections: b.4, e.1, e.3, g.3, g.6, h.2, and h.10.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00814.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the independent physician review of the three video files of the procedure that was included in the complaint file.The videos were reviewed by the senior medical affairs director ¿ dr.(b)(6), on (b)(6) 2023.The assessment reads as follows: ¿there is a detailed description of the events that happened during the procedure with some unknown items as described above.There is footage of the procedure available which added to 2.5 hours of recorded procedure.In this material, there is a normal positioning of the pulserider and uneventful coiling up until the problem occurs.There is no clear indication as to which coil prolapsed, but since the index coil was removed it must have been a prior coil.From the imaging provided, the underlying cause/causes leading to coil prolapse cannot be ascertained.After the event of coil prolapse, images demonstrate the deployment of an atlas stent, which is an elegant way of overcoming the coil protrusion as well as maintaining arterial lumen patency.There are no further complications visible at the end of the procedure.Submission of the index coil to the company is recommended for further evaluation of potential failures.¿ physician name and date reviewed: (b)(6), (b)(6) 2023.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00814 and 3008114965-2022-00815.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: PULSERIDER T, 3MM, 8MM ARCH
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 15944885
• MDR Text Key: 305149212
• Report Number: 3008114965-2022-00815
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 00859030005154
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H160002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: 3076825513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EXCELSIOR® SL-10® MICROCATHETER (STRYKER); GALAXY G3 MINI 1MM X 3CM; MICROCATHETER; NEUROFORM ATLAS® STENT SYSTEM (STRYKER); SOFIA ¿ DISTAL ACCESS CATHETER (MICROVENTION)
• Patient Outcome(s): Required Intervention